Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride, Quantity: 2 mg/mL
Boucher & Muir Pty Ltd
Ropivacaine hydrochloride
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid; sodium chloride
Epidural, Intrathecal, Mucosal, Subcutaneous, Intraneural, Intradermal, Intracutaneous, Infiltration, Intramuscular
200 mL bags in packs of 5
(S4) Prescription Only Medicine
Surgical anaesthesia (adults and children over 12 years of age),? epidural block for surgery including caesarean section,? intrathecal anaesthesia,? field block (minor nerve block and infiltration),? major nerve block,Analgesia (adults and children over 12 years of age),? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,? field block (minor nerve block and infiltration),? continuous peripheral nerve block infusion or intermittent injections for post operative pain management,? continuous wound infusion for postoperative pain management (adults only),Analgesia (children aged 0 - 12 years),? caudal epidural block in neonates (> 37 weeks gestation and over 2,500 g weight), infants and children up to and including 12 years,? continuous epidural infusion in infants (> 30 days and over 2,500 g weight) and children up to and including 12 years,? peripheral nerve block in children aged 1 up to and including 12 years,For peri- and postoperative pain management.,There are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).
Visual Identification: A clear, colourless solution; Container Type: Bag; Container Material: PP; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-03-09
ROPIBAM _SOLUTION FOR INJECTION 0.2%, 0.75% AND 1%_ _Ropivacaine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Ropibam. This leaflet answers some common questions about Ropibam. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Ropibam against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT ROPIBAM IS USED FOR Ropibam contains ropivacaine hydrochloride which is a local anaesthetic. It is injected into the body where it makes the nerves unable to pass messages to the brain. Depending on the amount used, Ropibam will either totally stop pain or will cause a partial loss of feeling. Ropibam is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. It is also used after surgery to treat post- operative pain. Your doctor will have explained why you are being treated with Ropibam and told you what dose you will be given. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Ropibam is available only with a doctor’s prescription. Ropibam is not addictive. BEFORE YOU ARE GIVEN ROPIBAM Ropibam is not suitable for everyone. _WHEN YOU MUST NOT BE GIVEN_ _IT_ Ropibam must not be given if you: • are allergic to any medicine containing ropivacaine, any other local anaesthetics, or any of the ingredients listed at the end of this leaflet • have problems controlling your low blood pressure • have inflammation and/or an infection at the site of injection. ROPIBAM MUST NOT BE USED AFTER THE EXP Lesen Sie das vollständige Dokument
ROPIBAM 1 AUSTRALIAN PRODUCT INFORMATION ROPIBAM 0.2%, 0.75% & 1% ROPIVACAINE HYDROCHLORIDE INJECTION SOLUTIONS FOR THE PRODUCTION OF LOCAL OR REGIONAL ANAESTHESIA NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 1 NAME OF THE MEDICINE ropivacaine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 2mg, 7.5mg or 10mg of Ropivacaine hydrochloride. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 - 6.0 during the approved shelf-life. The nominal osmolality of Ropibam 0.2% (2 mg/mL) is 284 mosmol/kg. The solution is preservative free. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Ropibam solution for injection is a sterile, clear, colourless, isotonic, isobaric, aqueous solution of ropivacaine HCl in water for injections. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SURGICAL ANAESTHESIA (ADULTS AND CHILDREN OVER 12 YEARS OF AGE) • epidural block for surgery including caesarean section • intrathecal anaesthesia • field block (minor nerve block and infiltration) • major nerve block ANALGESIA (ADULTS AND CHILDREN OVER 12 YEARS OF AGE) • continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain • field block (minor nerve block and infiltration) ROPIBAM 2 • continuous peripheral nerve block infusion or intermittent injections for post-operative pain management • continuous wound infusion for postoperative pain management (adults only) ANALGESIA (CHILDREN AGED 0 - 12 YEARS) • caudal epidural block in neonates (> 37 weeks gestation and over 2,500 g weight), infants and children up to and including 12 years • continuous epidural infusion in infants (> 30 days and over 2,500 g weight) and children up to and including 12 years • peripheral nerve block in children aged 1 up to and including 12 years For peri- and postoperative pain management. There are no safety or efficacy data to support Lesen Sie das vollständige Dokument